Japan Reach Regulation for Various Sectors

The Cosmetic Act is issued by the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and it is supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW). The main regulations concerning cosmetics in Japan are  “Pharmaceutical and Medical Device Law”(issued 14/09/2019)  and “Standards for Cosmetics”(issued 01/04/2001)

There are more than 10 Existing Key Cosmetic Regulations in force, for example, “Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices”, which came into force on September 14^th, 2019.

According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.

Cosmetic products include two main categories in Japan.

1. Cosmetics: products that aim to maintain beauty, which can enter the market without notification nor registration.
2. Quasi-drugs: products that contain an active ingredient with a weak but real pharmacological activity on the human body (while not falling into the category of drugs) and aim at prevention and modification, which need approvement by authorities to enter the market.

The common quasi-drugs product types in Japan include the following:

• Anti-dandruff
• Whitening
• Anti-acne
• Anti-bacterial
• Anti-chapping
• Against drought
• Medicated soaps
• Haircare
• Deodorant
• Antiperspirant
• Product for hair regrowth
• Hair dyes
• Perm products
• Toothpaste
• Bath salts
• Products for breath
• Oral care

Ingredients:

1. Actives: the registration is easier for recognized actives that are already listed, but it is also possible to use new active(s)
2. Excipients: limited to the positive ingredient list (around 8000 substances), but also possible to use new excipient(s)

A thorough documentation of the active ingredient should be provided to the Pharmacy agency: Pre-Marketing Registration and Approval (PMDA). The agency will fully verify the product and claimed effects and then a specific labelling with the term "quasi drug" will be provided. A monograph is possible to follow for certain products.

The ingredients

"The ingredients of cosmetic products, including the impurities they contain, must not contain anything that could cause infection or make the use of cosmetic products hazardous to health” --Standard for Cosmetics

To help the manufacturers with their formulation, the Cosmetic Act has establish the following documents :

• Prohibited substances list, it is annexed to the Standard for Cosmetics. It gathers 30 prohibited substances, the Class I and II lists of the Chemical Substances Control Law (CSCL) and the substances from the Poisonous and Deleterious Substances Control Act.
• A restricted substances list
• An authorized preservatives list
• A positive list of the UV filters

The Label and claims

The labelling should be in Japanese and present the following :

• Name and Address of Marketing License Holder
• Product name
• Batch number
• Net weight
• List of ingredients (Japanese INCI)
• The expiry date for cosmetics specified by the MHLW announcement
• Precautions for use, instructions for use
• Country of origin

"Codes on Fair Competition regarding the representations of cosmetics" are Volontary standards on labelling and claims which are widely observed in Japan.

A list of 56 accepted efficacy claims for cosmetics is establish to prevent companies from giving unreasonable premiums and misleading representations claims. The Cosmetic Act :

• Ban wrong, misleading or exaggerated statements
• Prohibit assigning unprovable properties to the product
• Inhibit claims related to quasi-drugs or drugs for cosmetics